# FDA 483 - Phoenix Deventures - February 15, 2023

Source: https://www.globalkeysolutions.net/records/483/phoenix-deventures/daafd567-9faf-4cb0-aa64-f80754fbb4be

> FDA 483 for Phoenix Deventures on February 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phoenix Deventures
- Inspection Date: 2023-02-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Phoenix Deventures, a medical device manufacturer in Morgan Hill, CA, was inspected by the FDA from February 3-15, 2023. The inspection revealed significant deficiencies across multiple quality system areas, including management review, material control, equipment calibration, complaint handling, CAPA documentation, supplier controls, and non-conforming product management. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements.

## Related Officers

- [Jeffrey S Buckser](https://www.globalkeysolutions.net/people/jeffrey-s-buckser/deea4f9e-858f-4325-828e-56044c40a570)

Company: https://www.globalkeysolutions.net/companies/phoenix-deventures/660e347c-a07b-4d8b-9569-7132bfa22e37

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b